EP3960164A4 - METHOD FOR PRODUCING A PHARMACEUTICAL FORMULATION - Google Patents

METHOD FOR PRODUCING A PHARMACEUTICAL FORMULATION Download PDF

Info

Publication number
EP3960164A4
EP3960164A4 EP20795882.8A EP20795882A EP3960164A4 EP 3960164 A4 EP3960164 A4 EP 3960164A4 EP 20795882 A EP20795882 A EP 20795882A EP 3960164 A4 EP3960164 A4 EP 3960164A4
Authority
EP
European Patent Office
Prior art keywords
preparation
pharmaceutical formulation
formulation
pharmaceutical
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP20795882.8A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3960164A1 (en
Inventor
Yoshio Nakano
Tomohiro Hayashida
Yohei Hoashi
Keisuke Edamura
Yuki Ichikawa
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nipro Corp
Original Assignee
Nipro Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nipro Corp filed Critical Nipro Corp
Publication of EP3960164A1 publication Critical patent/EP3960164A1/en
Publication of EP3960164A4 publication Critical patent/EP3960164A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/005—Coating of tablets or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
    • A61K31/558—Eicosanoids, e.g. leukotrienes or prostaglandins having heterocyclic rings containing oxygen as the only ring hetero atom, e.g. thromboxanes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
EP20795882.8A 2019-04-22 2020-04-21 METHOD FOR PRODUCING A PHARMACEUTICAL FORMULATION Withdrawn EP3960164A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2019081372 2019-04-22
PCT/JP2020/017254 WO2020218310A1 (ja) 2019-04-22 2020-04-21 医薬製剤の製造方法

Publications (2)

Publication Number Publication Date
EP3960164A1 EP3960164A1 (en) 2022-03-02
EP3960164A4 true EP3960164A4 (en) 2023-01-11

Family

ID=72942128

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20795882.8A Withdrawn EP3960164A4 (en) 2019-04-22 2020-04-21 METHOD FOR PRODUCING A PHARMACEUTICAL FORMULATION

Country Status (5)

Country Link
US (1) US20220218617A1 (enrdf_load_stackoverflow)
EP (1) EP3960164A4 (enrdf_load_stackoverflow)
JP (1) JPWO2020218310A1 (enrdf_load_stackoverflow)
CN (1) CN113874000A (enrdf_load_stackoverflow)
WO (1) WO2020218310A1 (enrdf_load_stackoverflow)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024108113A1 (en) * 2022-11-18 2024-05-23 Merck Sharp & Dohme Llc Method and apparatus for controlling a mini-tablet manufacturing machine incorporating content uniformity testing requirements
JP7623427B2 (ja) 2023-06-16 2025-01-28 沢井製薬株式会社 印字を有する錠剤の製造方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005123569A2 (en) * 2004-06-09 2005-12-29 Smithkline Beecham Corporation Apparatus and method for pharmaceutical production
US20060002986A1 (en) * 2004-06-09 2006-01-05 Smithkline Beecham Corporation Pharmaceutical product
GB2512098A (en) * 2013-03-20 2014-09-24 Roly Bufton An oral dosage form

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2849494A1 (de) 1978-11-15 1980-05-29 Voss Gunter M Verfahren zur herstellung von arzneimittel-formlingen
US20040173146A1 (en) * 2001-06-07 2004-09-09 Figueroa Iddys D. Application of a bioactive agent to a delivery substrate
US20040173147A1 (en) * 2001-06-07 2004-09-09 Figueroa Iddys D. Application of a bioactive agent to a delivery substrate
GB0322485D0 (en) * 2003-09-25 2003-10-29 Disperse Ltd Process for the preparation of surface coatings or dry films
US20050202051A1 (en) 2004-03-15 2005-09-15 Chinea Vanessa I. Pharmaceutical vehicle
JP2006006303A (ja) 2004-06-29 2006-01-12 Cel:Kk 釣り針と製造方法、その仕掛け及び結合方法と使用方法
JP4756153B2 (ja) 2004-08-27 2011-08-24 富士製薬工業株式会社 低成分含量の錠剤の製造方法
EP1884233A1 (en) * 2005-05-26 2008-02-06 Eisai R&D Management Co., Ltd. Method of marking composition for oral administration
US9381154B2 (en) * 2011-06-09 2016-07-05 Xerox Corporation Direct inkjet fabrication of drug delivery devices
JP2014114280A (ja) * 2012-11-14 2014-06-26 Ohara Yakuhin Kogyo Kk 印刷に適した錠剤の製造法
JP5836980B2 (ja) * 2013-01-11 2015-12-24 信越化学工業株式会社 薬物含有粒子、固形製剤及び薬物含有粒子の製造方法
WO2016117518A1 (ja) * 2015-01-21 2016-07-28 クオリカプス株式会社 インク及びこれを用いた可食体の製造方法並びに可食体の印刷方法
JP2016160250A (ja) * 2015-03-05 2016-09-05 大原薬品工業株式会社 医薬品錠剤の識別性のための印刷方法
JP2016203218A (ja) 2015-04-24 2016-12-08 株式会社菊水製作所 成形品収集装置及びこれを備えた粉体圧縮成形機
JP2016203235A (ja) 2015-04-28 2016-12-08 株式会社菊水製作所 ホッパー着脱装置及びこれを備えた粉体圧縮成形機
JP6637276B2 (ja) * 2015-09-18 2020-01-29 株式会社Ｓｃｒｅｅｎホールディングス インクジェット用水性インク組成物及び固体製剤
WO2018135410A1 (ja) 2017-01-17 2018-07-26 フロイント産業株式会社 錠剤製造装置及び錠剤製造方法並びに錠剤
JP3215836U (ja) 2018-02-05 2018-04-19 株式会社菊水製作所 成形品搬送モジュール

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005123569A2 (en) * 2004-06-09 2005-12-29 Smithkline Beecham Corporation Apparatus and method for pharmaceutical production
US20060002986A1 (en) * 2004-06-09 2006-01-05 Smithkline Beecham Corporation Pharmaceutical product
GB2512098A (en) * 2013-03-20 2014-09-24 Roly Bufton An oral dosage form

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2020218310A1 *

Also Published As

Publication number Publication date
EP3960164A1 (en) 2022-03-02
JPWO2020218310A1 (enrdf_load_stackoverflow) 2020-10-29
CN113874000A (zh) 2021-12-31
US20220218617A1 (en) 2022-07-14
WO2020218310A1 (ja) 2020-10-29

Similar Documents

Publication Publication Date Title
EP3929543C0 (en) SYSTEM AND METHOD FOR PREPARING A PHARMACEUTICAL COMPOUND
EP3702346A4 (en) HEXAFLUOROBUTADIENE PRODUCTION PROCESS
EP3960868A4 (en) Polyhydroxyalkanoic acid and method for producing same
EP3865468A4 (en) PROCESS FOR MANUFACTURING PERFLUOROALKYNE COMPOUND
EP3930704A4 (en) COMPOSITIONS COMPRISING CINNAMIC ACID AND METHODS OF USE THEREOF
EP4388119A4 (en) PROCESS FOR PRODUCING A PHARMACEUTICAL COMPOSITION
EP4019485C0 (en) PROCESS FOR THE PRODUCTION OF HETEROCYCLIDENE ACETAMIDE DERIVATIVES
EP3696168A4 (en) PROCESS FOR THE PREPARATION OF 2-CHLORO-5-TRIFLUOROMETHYLPYRIDINE
EP3980013A4 (en) Processes for preparing aminopyrimidine compounds
EP3957600A4 (en) Method for producing sulfide solid electrolyte
EP3773505A4 (en) PROCESSES FOR THE CONTINUOUS MANUFACTURE OF LIPOSOMAL DRUG PRODUCTS
EP3960164A4 (en) METHOD FOR PRODUCING A PHARMACEUTICAL FORMULATION
EP3874553A4 (en) Method of making a layered electrolyte
EP3831804A4 (en) Method for producing 1-acyloxy-2-methyl-2-propene
EP3950379A4 (en) Rubber composition and method for producing rubber composition
EP3757146A4 (en) PROCESS FOR MANUFACTURING A SOLUTION INCLUDING AN AQUEOUS CARBODIIMIDE
EP3984982A4 (en) PROCESS FOR THE PRODUCTION OF A MORPHINANE DERIVATIVE
EP3612167A4 (en) METHOD FOR PREPARING AN ORAL DISINTEGRATION DOSAGE FORM
EP3943159A4 (en) Production method of quinolinecarboxamide derivative or production intermediate thereof
EP3854786A4 (en) METHOD FOR PRODUCTION OF AMINO ACID DERIVATIVES
EP3889125A4 (en) METHOD FOR PRODUCING A DIVINE ETHER COMPOUND HAVING AN ALKYLENE SKELETON
EP3782999A4 (en) PROCESS FOR THE SYNTHESIS OF A 3-PHENYL-2,8-DIHYDROPYRANO [2,3-F] CHROMENE DERIVATIVE
EP3808261A4 (en) Method for producing bioelectrode
EP3642190A4 (en) PROCESS FOR MANUFACTURING ESTERS OF 2,5-FURANDICARBOXYLIC ACID
EP3727377A4 (en) PROCESS FOR THE PREPARATION OF PYRIMIDINYL-4-AMINOPYRAZOLE COMPOUNDS

Legal Events

Date Code Title Description
STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20211022

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
TPAC Observations filed by third parties

Free format text: ORIGINAL CODE: EPIDOSNTIPA

REG Reference to a national code

Ref country code: DE

Ref legal event code: R079

Free format text: PREVIOUS MAIN CLASS: A61K0009280000

Ipc: A61J0003060000

A4 Supplementary search report drawn up and despatched

Effective date: 20221214

RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 9/28 20060101ALI20221208BHEP

Ipc: A61K 31/558 20060101ALI20221208BHEP

Ipc: A61K 31/519 20060101ALI20221208BHEP

Ipc: A61K 31/137 20060101ALI20221208BHEP

Ipc: A61K 9/20 20060101ALI20221208BHEP

Ipc: A61J 3/00 20060101ALI20221208BHEP

Ipc: A61J 3/06 20060101AFI20221208BHEP

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20230722